2026 data FDA MAUDE openFDA FDA Class II

System, Test, Vitamin D

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1825 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book System, Test, Vitamin D LIGHT-BOOK · MAUDE

#986 of 1000 · 379 reports · 2009–2026

  • BOOK 379 reports
  • RANK #986 of 1000
  • DEATH 0 death-typed
  • INJ 3 injury-typed
  • MALF 375 malfunction
  • SPAN 2009–2026
  • PEAK 2018: 75
  • PHOTO Gram Negative Identif…

Nearest event-volume peer: Gram Negative Identification Panel (2 report gap)

System, Test, Vitamin D sits #986 of 1000 among tracked device types with 379 MAUDE reports spanning 2009–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

System, Test, Vitamin D carries 98.9% MALFUNCTION-coded reports, 34.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.8% corpus 30.3% · below corpus mean (-29.5 pp)
  • MALF 98.9% corpus 64.8% · above corpus mean (+34.1 pp)

Lead product-problem code High Test Results is 45% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 83% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

System, Test, Vitamin D in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows System, Test, Vitamin D carries 379 MAUDE reports, ranked #986 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 375 (98.9%)
Injury 3 (0.8%)
Other 1 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

373 (98.4%)
Other 6 (1.6%)

Top Product Problems

High Test Results 235
Non Reproducible Results 112
Low Test Results 56
Incorrect Or Inadequate Test Results 40
Incorrect, Inadequate or Imprecise Result or Readings 27
Adverse Event Without Identified Device or Use Problem 15
Incorrect Measurement 8
Insufficient Device Problem Information 5
Low Readings 5
High Readings 4
Material Integrity Problem 3
Calibration Error 2
Calibration Problem 2
Chemical Problem 2
Device Damaged Prior to Use 2
No Device Output 2
Output Problem 2
Signal Artifact/Noise 2
Unable to Obtain Readings 2
Appropriate Device Problem Term/Code Not Available 1

Yearly Trend

09
2009: 1
11
2011: 1
12
2012: 23
13
2013: 21
14
2014: 14
15
2015: 18
16
2016: 14
17
2017: 21
18
2018: 75
19
2019: 38
20
2020: 10
21
2021: 15
22
2022: 13
23
2023: 22
24
2024: 32
25
2025: 29
26
2026: 32

Reports in 2025 (29) held close to the prior two-year average of 27.

Related Entities for System, Test, Vitamin D

Event Locations

183 (48.3%)
I 170 (44.9%)
LABORATORY 23 (6.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.5%)
OUTPATIENT TREATMENT FACILITY 1 (0.3%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS, INC. →

Nationwide devices with a comparable report-volume footprint

System, Test, Vitamin D carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (379 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for System, Test, Vitamin D are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Test, Vitamin D; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.